Cleared Traditional

K003264 - QPS/BPGS/MOCO PROCESSING APPLICATIONS F...

K003264 is an FDA 510(k) clearance for QPS/BPGS/MOCO PROCESSING APPLICATIONS F..., manufactured by Ge Medical Systems F.I. Haifa. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K003264 · Ge Medical Systems F.I. Haifa · Radiology device
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Dec 2000
Decision
64d
Days
Class 2
Risk

K003264 is an FDA 510(k) clearance for the QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Ge Medical Systems F.I. Haifa (Tirat Hacarmel, IL). The FDA issued a Cleared decision on December 21, 2000 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ge Medical Systems F.I. Haifa devices

FDA 510(k) Submission Details - K003264

510(k) Number K003264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2000
Decision Date December 21, 2000
Days to Decision 64 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 107d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KPS System, Tomography, Computed, Emission

All 251
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K003264.
GE VISION NUCLEAR MEDICINE WORKSTATION
K012568 · General Electric Co. · Sep 2001
ORBITER II CCI/SPECT ORBITER II CCI/SPECT
K010137 · Siemens Medical Solutions USA, Inc. · Feb 2001
GE ADVANCE NXI PET SYSTEM
K003849 · Ge Medical Systems, Inc. · Dec 2000
ALLEGRO TB, ALLEGRO N
K003434 · Adac Laboratories · Nov 2000
SKYLIGHT IMAGING SYSTEM
K000908 · Adac Laboratories · Apr 2000
AUTOMATIC IMAGE REGISTRATION SOFTWARE, MODEL NSFU-050A
K992992 · Toshiba America Medical Systems, In.C · Dec 1999